> IDIX note- Dew what are you opinions of the news based on the fact that the 800mg patients w/ virus levels below 600 IU/mL were randomized to 200 and 400mg arms at the re-dosing? Some skewing is obviously present due to these 800mg patients being re-assigned and the "non-responders" being eliminated from the trial.<
The protocol change does make it harder to interpret the data, but this has been known since the March 24 CC. Other than scrapping the trial entirely, I don’t know how IDIX and the FDA could have handled the change any better.
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